Nxera Pharma Secures Exclusive Rights to Fabry Disease Phase 3 Oral Therapy Candidate Lucerastat

Nxera Pharma has exercised its option to license lucerastat from Idorsia and has entered into a co-development and commercialization agreement, pursuant to which Nxera will hold exclusive rights to develop and commercialize lucerastat in Japan, South Korea, Taiwan and selected other Asia Pacific markets, excluding China (the "Territory").

Orrick advised Nxera.

THE COMPANIES

Nxera Pharma is a technology-powered biopharma company in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally.

Idorsia's purpose is to discover, develop and commercialize innovative medicines to help more patients.

THE IMPACT

Idorsia granted Nxera the option in July 2023, as part of Nxera's (then Sosei Heptares) acquisition of Idorsia's Asia Pacific (ex-China) operations.

Nxera will pay Idorsia an upfront payment of 7 million Swiss francs, in line with the pre-agreed option terms, and will also contribute to the global Phase 3 development program. Idorsia is eligible to receive royalties on net sales in the Territory.

Fabry disease is a rare, inherited condition in which a fatty substance called Gb3 builds up in cells, progressively damaging the kidneys, heart and nervous system. Lucerastat is designed to reduce the production of Gb3 and to work regardless of a patient's genetic mutation or prior treatment. In Idorsia's Phase 3 MODIFY study and its long-term extension, lucerastat showed sustained reductions in Gb3 and was associated with a slower rate of kidney function decline compared with the period before treatment. Some patients in the clinical trial have now received lucerastat for more than six years.

Idorsia's global Phase 3 program includes FAB-KLEAR, a kidney biopsy study in 16 adult male patients, and a 74-patient study comparing lucerastat with standard-of-care enzyme replacement therapies on kidney function. The program has been aligned with the US FDA on a streamlined registration strategy and is also in line with feedback received from the European Medicines Agency. Nxera will take part in the comparative 2 of 3 kidney function study and will be responsible for managing clinical development in Japan.

THE TEAM

The Orrick team was led by David Schulman and Edward Dyson, with invaluable support from Megan McKnelly.

LEARN MORE

• Nxera News Release